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Associate/Senior Associate, Clinical Systems Management

1-5 years
Not Disclosed
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate/Senior Associate, Clinical Systems Management
Location: Cork, Cork, Ireland
Category: Research & Development
Job Type: Full-Time, Regular
Job Id: R-79074


Company Overview:

At Eli Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, we are committed to discovering life-changing medicines and improving the understanding and management of diseases. Our employees around the globe strive to deliver innovative solutions that enhance lives, with a culture rooted in philanthropy, volunteerism, and diversity.

Eli Lilly Cork is home to over 2,000 employees representing more than 60 nationalities, working across functions like Finance, Information Technology, Medical, and Clinical Trials. Our campus offers a premium workspace with flexible hybrid working options, comprehensive benefits, and a focus on employee well-being.

Eli Lilly Cork is committed to diversity, equity, and inclusion (DEI) with a focus on creating an inclusive environment for all employees. We embrace all ethnicities, backgrounds, and identities through initiatives like EnAble, Age & Culture, LGBTQ+ & Ally, and GIN-Gender Inclusion Network.


Position Overview:

The Associate/Senior Associate, Clinical Systems Management will be a key member of the Clinical Design, Delivery & Analytics (CDDA) team, responsible for supporting the systems used in the management of clinical trials. Based in our Global Business Solutions (GBS) center in Cork, this role will work closely with cross-functional teams, including CDDA, Information & Digital Solutions (IDS), and other areas within R&D, to ensure the operational, compliance, and quality status of critical business systems supporting clinical trials.

You will play an essential role in maintaining and enhancing clinical trial systems, driving system support, and improving overall functionality to meet the needs of stakeholders.


Key Responsibilities:

  • System Management:

    • Maintain and grow a strong working knowledge of clinical trial systems used across CDDA.
    • Manage CDDA business systems by providing technical expertise and supporting maintenance and deployment activities.
    • Ensure timely installation of new system releases and patches, including offering related training and business process development.
  • Issue Resolution:

    • Quickly resolve system issues to ensure uninterrupted access and minimize disruptions.
    • Apply root cause analysis to identify and address system issues effectively.
  • Continuous Improvement:

    • Proactively identify system risks, issues, and opportunities for improvement.
    • Collaborate with cross-functional teams to drive system improvements and optimize functionality and efficiency.
  • Customer Focus:

    • Respond to and act upon customer feedback related to systems.
    • Support internal and external audits, ensuring systems are compliant with regulatory and quality requirements.
  • Training & Support:

    • Develop and support user training, including the creation of job aids, FAQs, and knowledge base materials.
    • Assist with data migration activities and conduct quality checks to ensure accuracy.
  • Metrics & Reporting:

    • Develop and maintain system metrics to track performance and identify areas for improvement.

Minimum Qualifications:

  • Bachelor’s degree in Computer Science, Information Technology, or a related field.
  • Experience in medical, clinical, or quality systems, or clinical information flow within the drug development process.

Preferred Qualifications:

  • Advanced degree in a relevant field.
  • Experience working with clinical development data systems and evolving technologies to support clinical trials.
  • Knowledge of data migration, reporting, and project management practices.
  • Understanding of regulatory and quality requirements governing clinical data development.

Key Skills:

  • Strong logical thinking, problem-solving, and critical thinking skills.
  • Excellent communication skills, both written and verbal, with the ability to communicate complex technical concepts to non-technical stakeholders.
  • Ability to work effectively in cross-functional teams and manage conflict to drive progress.
  • Strong collaboration skills and the ability to build consensus and resolve issues.
  • Customer-focused with a commitment to delivering value through system functionality and support.

Additional Information:

  • Minimal travel required (<10%).
  • Eli Lilly is committed to supporting individuals with disabilities in the workforce. If you require accommodation to apply, please complete the accommodation request form on our careers page.

Eli Lilly is an equal opportunity employer and does not discriminate based on age, race, religion, gender, sexual orientation, gender identity, disability, or any other legally protected status.


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